# K230272: Renuvion® APR Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation
- Decided: Apr 27, 2023 after 86 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894762 (1989). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220970: Renuvion APR Handpiece, Apyx Medical Corporation (Formerly Bovie Medical Corporation) (2022) Summary page 5.
- K223262: Renuvion® APR Handpiece, Apyx Medical Corporation (2023). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K230586: Renuvion® Micro Handpiece (2023), 0 descendants of its own

## Indications for use
Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue. The Renuvion APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. The Renuvion APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region. The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.

Source page: https://510kreport.com/device/K230272
Methodology: https://510kreport.com/methodology